Guardant Health said the FDA approved its Guardant360 CDx assay as a companion diagnostic for Boehringer Ingelheim’s HER2-mutant lung cancer drug Hernexeos (zongertinib). The liquid biopsy test identifies tumors harboring HER2 kinase domain activating mutations to support treatment selection in adults with unresectable or metastatic non-squamous non-small cell lung cancer, with accelerated approval tied to clinical endpoints. The decision marks the 27th CDx indication for the Guardant platform, reinforcing the role of broad, multiplex liquid biopsy panels in pairing targeted therapies to biomarker-defined patient subsets for faster clinical decision-making.